International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS)

The role of ELSIE in evolving current thinking on extractables and leachables

20 February 2020 | By Dave Elder (JPAG Member and David P Elder Consultancy)

Extractables and Leachables Safety Information Exchange (ELSIE) has been the most influential industry group in developing guidelines for extractables and leachables. In the wake of the ICH convening a new group to develop a concept paper and business plan on their Q3E Impurity Guideline, Dave Elder discusses the strides that…

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International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS)

The role of ELSIE in evolving current thinking on extractables and leachables